Breast MRI in nonpalpable breast lesions: a randomized trial with diagnostic and therapeutic outcome - MONET - study.

Nicky H G M Peters,Peter W Plaisier,Maurice A A J Van Den Bosch,Adriaan J Van Overbeeke,Inne H M Borel Rinkes,Willem P T M Mali,Petra H M Peeters,Erwin De Boer,Petra H M Peeters,Remmert K Storm,Petra H M Peeters

doi:10.1186/1745-6215-8-40

Abstract

BackgroundIn recent years there has been an increasing interest in MRI as a non-invasive diagnostic modality for the work-up of suspicious breast lesions. The additional value of Breast MRI lies mainly in its capacity to detect multicentric and multifocal disease, to detect invasive components in ductal carcinoma in situ lesions and to depict the tumor in a 3-dimensional image. Breast MRI therefore has the potential to improve the diagnosis and provide better preoperative staging and possibly surgical care in patients with breast cancer. The aim of our study is to assess whether performing contrast enhanced Breast MRI can reduce the number of surgical procedures due to better preoperative staging and whether a subgroup of women with suspicious nonpalpable breast lesions can be identified in which the combination of mammography, ultrasound and state-of-the-art contrast-enhanced Breast MRI can provide a definite diagnosis.Methods/DesignThe MONET – study (MR mammography Of Nonpalpable BrEast Tumors) is a randomized controlled trial with diagnostic and therapeutic endpoints. We aim to include 500 patients with nonpalpable suspicious breast lesions who are referred for biopsy. With this number of patients, the expected 12% reduction in surgical procedures due to more accurate preoperative staging with Breast MRI can be detected with a high power (90%). The secondary outcome is the positive and negative predictive value of contrast enhanced Breast MRI. If the predictive values are deemed sufficiently close to those for large core biopsy then the latter, invasive, procedure could possibly be avoided in some women. The rationale, study design and the baseline characteristics of the first 100 included patients are described.Trial registrationStudy protocol number NCT00302120

Highlights

In recent years there has been an increasing interest in MRI as a non-invasive diagnostic modality for the work-up of suspicious breast lesions
Of all suspicious nonpalpable breast lesions, 10–55% of lesions turn out to be malignant after large core needle biopsy (LCNB) depending on the aggressiveness of the referral of patients which varies across countries [4]
The purpose of the MONET – study is to evaluate whether performing contrast-enhanced Breast MRI in addition to mammography and/or ultrasound in patients with nonpalpable suspicious breast lesions will improve breast cancer management, i.e. to reduce the number of surgical procedures and/or the number of large core needle biopsies

Summary

Introduction

In recent years there has been an increasing interest in MRI as a non-invasive diagnostic modality for the work-up of suspicious breast lesions. Like many other Western countries, the Netherlands launched a screening program for breast cancer and since 1998, all women between 50 and 75 years of age are offered biannual mammographic examination This program reveals approximately 4000 suspicious, nonpalpable breast lesions each year in the Netherlands [2]. Of all suspicious nonpalpable breast lesions, 10–55% of lesions turn out to be malignant (ductal carcinoma in situ or invasive carcinoma) after large core needle biopsy (LCNB) depending on the aggressiveness of the referral of patients which varies across countries [4]. These patients are scheduled for surgical removal of the malignant breast tumor. A more accurate preoperative diagnosis could help to reduce the number of surgical procedures and invasive biopsies

Objectives

Methods

Findings

Conclusion